According to the US GMPS "The suitability of all testing methods shall be verified under actual conditions of use". This is supported by the USP, which states "Users of compendial analytical procedures are not required to validate these procedures when first used in their laboratories, but documented evidence of suitability should be established under actual conditions of use." A modified definition of the accepted definition of test method validation "Documented evidence that the test method performs as intended in the using laboratory" supports the concept of method verification. It is clear that when a test method is moved into any laboratory that has not performed the test before the firm must do something to demonstrate that the test method performs as intended. The transfer could be from the method development laboratory to the internal Quality Control testing laboratory or a laboratory supporting a contract manufacturer. The firm must demonstrate that the receiving laboratory is capable of performing the test and that the test results accurately reflect the attribute being tested.
The term method verification took on a new meaning when the USP published its stimulus article on the test method lifecycle that proposes Continued Test Method Verification during stage 3 of the test method lifecycle.
This webinar will discuss test method verification and what should be considered for the method verification project.
Why should you Attend:
The verification of Test Methods has been the subject of FDA 483 observations and warning letters. Laboratory managers and personnel should understand what is required for the transfer of a test method into a laboratory.
Test method verification is required by the GMPs and there is a USP chapter covering the topic.However,many companies do not understand what should be done for a thorough, successful test method transfer.
The requirement for method transfer begins when the method is moved from the Method Development environment to the routine Quality Control testing laboratory. However, there should be a method transfer anytime a method is transferred from one laboratory to another. This would include the transfer of the method into a stability testing laboratory, or to a contract laboratory or the testing laboratory of a contract manufacturer.
Areas Covered in the Session:
The requirements for test method verification when a method is transferred from one laboratory to another
What might be included in the method verification that accompanies a test method transfer
The regulatory and compendial expectation for test method verification as as a part of the test method lifecycle
What might be included in continued test method verification
Who Will Benefit:
Analysists an any laboratory performing GMP testing
Any Laboratory anticipating performing Quality Control testing in the future
John (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions. In 1994 Dr. Lanese formed his own company, The Lanese Group, and since that time he has been a consultant in the area of quality system and cGMP compliance and has consulted with small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations. Dr. Lanese lectures throughout the world on a variety of topics related to Quality Systems, GMPs, APIs, laboratory operations, calibration, change control, deviations and product reviews for clients and national seminar and conference providers. He was named the Best Seminar Presenter of the year 2001 by the Institute of Validation Technology.
In 2005, his article “Training and the Laboratories” was selected as best article of year by the Journal of GXP Compliance. Recently, in 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry. Jerry is a member of the Editorial Board of the Journal of GXP Compliance. He has been active in the Kansas Award for Excellence program, a Baldrige Criteria based program, for the past fifteen years. He has served as Examiner, Lead Examiner and Judge and is currently the Director of the Kansas Award for Excellence Program. In addition, he served as a Baldrige Examiner in 2008. Dr. Lanese is also a member of American Society for Quality, AOAC and the Institute for Management Consultants and is a Certified Management Consultant (CMC). He is listed in Madison Who’s Who. He was active in the Kansas Award for Excellence program, a Baldrige Criteria based program, for seventeen years. He served as Examiner, Lead Examiner, Judge and the Director of the Kansas Award for Excellence Program. In addition, he served as a Baldrige Examiner in 2008. On the personal side, Jerry is active in two Toastmasters clubs in the Johnson County, KS area, and is the president of Kansas City Ragtime Revelry, an organization that promotes ragtime and early American music.